(29 days)
The ASAHI Corsair Armet 18 is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another.
The ASAHI Corsair Armet 18 is also intended to assist in the delivery of contract media into the peripheral vasculature.
This device should not be used in coronary vasculature or neurovasculature.
This product consists of a distal tip, a shaft tube, a protector and a connector. The distal tip and distal side of shaft are coated with hydrophilic coating on the outer surface. The tip is radiopaque, and the distal end is clearly distinguished by the tip.
The provided document, a 510(k) summary for the ASAHI Corsair Armet 18, describes the device's acceptance criteria and the study (non-clinical testing) used to demonstrate its substantial equivalence to a predicate device.
It's important to note that this device is a Percutaneous Catheter, and its performance evaluation relies on non-clinical bench testing rather than clinical studies involving human patients or complex AI algorithms processing medical images. Therefore, some of the requested information (like sample size for test/training sets for AI, expert adjudication, MRMC studies, or specific ground truth methodologies for image-based AI) is not applicable or present in this context.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Air Leakage | Met all acceptance criteria. |
| Appearance / Dimensions | Met all acceptance criteria. |
| Burst Pressure Under Static Condition | Met all acceptance criteria. |
| Corrosion Resistance | Met all acceptance criteria. |
| Kink Resistance | Met all acceptance criteria. |
| Liquid Leakage Under Pressure | Met all acceptance criteria. |
| Radio-Detectability | Met all acceptance criteria. |
| Slide Durability | Met all acceptance criteria. |
| Tensile Strength / Force at Break | Met all acceptance criteria. |
| Torque Durability | Met all acceptance criteria. |
| Torque Transmission | Met all acceptance criteria. |
| Overall Statement | "In the in vitro bench tests demonstrated that the ASAHI Corsair Armet 18 Microcatheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended, and is substantially equivalent to the predicate device. All ASAHI Corsair Armet 18 Microcatheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria." |
Note: The specific quantitative acceptance values for each test are not detailed in this summary but are implied to be established based on ISO10555-1 and/or internally validated procedures.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document repeatedly states "All ASAHI Corsair Armet 18 Microcatheter test samples" but does not specify the exact number of samples used for each test. This is typical for bench testing where a representative number of units are tested to ensure consistency and compliance.
- Data Provenance: The testing was "in vitro bench tests" performed on finished sterilized product. The applicant is ASAHI INTECC CO., LTD based in Japan, and the primary contact is in Tustin, California, USA. The testing itself would have been conducted in a laboratory, likely in-house or by a contracted lab. The data is retrospective in the sense that it's performed on manufactured devices for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable in this context. This device's evaluation is based on physical and mechanical performance characteristics of a medical device, not on diagnostic interpretations by human experts. The "ground truth" is defined by the objective measurement of physical properties against established engineering and medical device standards (ISO10555-1) and internal specifications.
4. Adjudication Method for the Test Set
- Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human review processes, typically in medical imaging studies where there's subjectivity in interpretation. For bench testing, results are quantitative and directly measured against pre-defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is compared. This document is for a medical catheter, not an AI diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical instrument, not an algorithm. Its "performance" is its ability to meet specified physical and mechanical criteria.
7. The Type of Ground Truth Used
- The ground truth is quantitative, objective physical and mechanical measurements against established international standards (ISO10555-1) and internally developed/validated acceptance criteria for various performance aspects (e.g., burst pressure, tensile strength, dimensions, kink resistance).
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device's non-clinical evaluation, as it is not an AI/machine learning product. The device itself is manufactured, and specific samples from the manufacturing process are chosen for testing.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI algorithm, this question does not apply. The "ground truth" for evaluating the catheter's performance is derived from engineering principles, relevant ISO standards, and established medical device design specifications.
Summary of Approach:
The evaluation of the ASAHI Corsair Armet 18 relies entirely on non-clinical bench testing to demonstrate that its physical and mechanical performance characteristics are substantially equivalent to a legally marketed predicate device (ASAHI Corsair Armet, K161362). The "acceptance criteria" are the thresholds or ranges for various engineering and material properties that the device must meet to ensure safety and effectiveness as a percutaneous catheter. The "study" involves performing a series of standardized tests on a set of manufactured devices and confirming that all tested samples meet these pre-defined criteria.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).